At a glance
ClinicalIndex Comparison Record- ✓Age 4–5 years (Cohort 1) or 6–12 years (Cohort 2) at screening
- ✓Body weight between 5th and 95th percentile for age and gender
- ✓DSM-5 ADHD diagnosis (combined, inattentive, or hyperactive/impulsive) confirmed by MINI Kid with symptoms present ≥6 months
- ✓CGI-S ≥4 (Moderately Ill) following any required ADHD medication washout
- ✕Bipolar I or II, major depression, conduct disorder, OCD, psychosis, autism spectrum disorder, DMDD, intellectual disability, Tourette syndrome, or confirmed genetic cognitive/behavioral disorder
- ✕Generalized anxiety disorder or panic disorder as primary treatment focus in past 12 months or requiring pharmacotherapy in past 6 months
- ✕Chronic CNS disease (tumors, inflammation, seizure disorder, serious head injury, or neuromuscular disorders)
- ✕Current or past 2-year use of anticonvulsants for seizure control or antidepressants (prior febrile or drug-induced seizure allowed)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Dose-Optimized, Randomized, Double Blind, Efficacy and Safety Study With Azstarys® in Children 4 to 12 Years of Age With Attention Deficit/Hyperactivity Disorder
In Brief
A Phase 4 clinical trial evaluating Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) and placebo for Attention Deficit/Hyperactivity Disorder. Completed, enrolled 246 participants across 20 sites.
Detailed Summary
This is a multicenter, dose-optimized, randomized, double-blind, placebo controlled, efficacy and safety study with Azstarys® in children 4 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD). Azstarys® contains dexmethylphenidate (d-MPH) and serdexmethylphenidate (SDX), a prodrug of d-MPH and is orally administered. The primary objective is to determine the efficacy of Azstarys® compared to placebo in treating children ages 4 to 12 years old with ADHD. The study will consist of two randomized and blinded treatment cohorts ages 4 to 5 years of age and 6 to 12 years of age. Randomization will be applied separately with a starting dose up-titration at different dose levels for each cohort. 130 and 100 subjects will be enrolled, respectively. Approximately 20 sites will participate.
Study Details
Timeline
Interventions
Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)
matching placebo